MAUDE Adverse Event Report: UNOMEDICAL S.R.O. GENTLECATH GLIDE; CATHETER, URETHRAL

Model Number	421571
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
End user reports "catheter was sealed into packaging during manufacturing".Photos depicting the reported complaint issue were provided by the complainant.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: 1049092.Manufacturing site: 3005778470.
Additional Manufacturer Narrative
Review of the dhr showed that all relevant tests required during the manufacturing process, packaging process and final product release had been fulfilled and met the requirements.No nonconformances were identified for this lot.The machine logbook was reviewed, and no records related to this issue were found.Additionally, no ncs were identified during the sterilization process.The percentage of affected pieces against lot is (b)(4).Affected quantity is within aql (b)(4).This complaint was presented on complaint review board on march 26, 2026.Attendees decided that this is considered an isolated issue and no further actions are required.Operators will be retrained according to g708002 education and training of production personnel (current version) and the issue will be presented to operators according to wi-001366 qa data visualization (current version).Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092.Manufacturing site: 3005778470.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: GENTLECATH GLIDE
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 24497852
• Report Number: 3005778470-2026-00413
• Device Sequence Number: 13229017
• Product Code: GBM
• UDI-Device Identifier: 30768455143574
• UDI-Public: 30768455143574
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161344
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 421571
• Device Lot Number: 5E01309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female